Needle safety device and assembly

ABSTRACT

Safety intravenous catheters (IVCs) are disclosed herein having a catheter hub with a catheter tube, a needle with a needle hub, and a needle guard. The needle guard is configured to be positioned at least partially within an interior space of the catheter hub and is retained thereto by mechanical engagement between the two. Following removal of the needle from the catheter hub, the needle guard is configured to disengage from the catheter hub and attach over a tip of the needle to shield the needle tip from inadvertent needlesticks. The needle guard having an angled end section configured with a length and a width to retain the needle tip within a tip holding space behind the angled end section.

CROSS-REFERENCE TO RELATED APPLICATION

This is a regular utility application of U.S. Provisional ApplicationNo. 61/371,054, filed Aug. 5, 2010, the contents of which are expresslyincorporated herein by reference.

BACKGROUND

The disclosure generally relates to needle safety assemblies and safetyintravenous catheters (IVCs), and, in particular, to a safety IVC inwhich the needle tip is automatically covered after needle withdrawal toprevent unintended needlestick with the needle tip.

DESCRIPTION OF RELATED ART

Intravenous catheters are primarily used to administer fluids directlyinto a patient's vascular system. Typically, a catheter is inserted intoa patient's vein by a health care worker. Immediately after thewithdrawal of the needle from the patient's vein, the exposed needle tipcreates a danger of an accidental needlestick occurring, which leavesthe health care worker vulnerable to the transmission of variousdangerous blood-borne pathogens.

This danger has led to the development of safety IVCs that cover or hidethe needle tip using several different means. However, some safety IVCsthat have been developed sometimes fail to prevent unintendedneedlesticks from occurring. For example, in some safety IVCs, theturning of the needle during removal may cause the needle tip to slideout from within the confines of the needle guard.

In some safety IVCs, the engagement that typically occurs between theneedle and the needle guard during withdrawal of the needle isunreliable.

SUMMARY

The various embodiments of the present safety IVC have several features,no single one of which is solely responsible for their desirableattributes. The prominent features of these embodiments will now bediscussed briefly without any intention of limiting the scope of theembodiments expressed herein.

In certain embodiments, a needle guard comprising a non-metallic baseportion comprising a bore, a proximally facing surface, and a distallyfacing surface are incorporated. The guard further includes a first armincluding a first free end and a second arm including a second free endextending generally axially from the base portion in a distal direction.The first free end extending beyond the second free end and including anangled end section that extends toward the second arm. Wherein theangled distal end section comprises a length and a width configured toretain a needle having a needle diameter within a tip holding space andwherein the length and width of the angled distal end section are largerthan the needle diameter.

In other embodiments, a catheter assembly comprising a needle guardcomprising: a non-metallic base portion comprising a bore, a proximallyfacing surface, and a distally facing surface is provided. The guardincludes a first arm including a first free end and a second armincluding a second free end extending generally axially in a distaldirection from the base portion. The first free end extend beyond thesecond free end and including an angled end section comprising a lengthand a width that extends toward the second arm and a needle having adiameter. Wherein the first arm and the second arm are biased so as tomove between a ready position in which the angled end section abuts aneedle having a needle tip and a protected position in which the needletip is confined within a tip holding space. Wherein the length and widthof the angled distal end section are larger than the needle diameter.

In yet another embodiment, a safety IVC comprising a needle hub with aneedle and a catheter hub with a catheter tube and a tip protector isprovided. The tip protector is made from a first material and having aproximal wall comprising an opening defining a bore and two armsextending distally of the proximal wall with at least one of the armscomprising an angled end section configured for covering a distal end ofthe other arm in a protective position. Wherein an insert made from asecond material comprising an opening is aligned with the opening of theproximal wall and wherein the opening of the proximal wall requires lessforce to enlarge than the opening of the insert.

Another embodiment of the present assembly includes a needle assemblycomprising a non-metallic base portion comprising wall having a bore, abore length, a bore diameter, a proximally facing surface, and adistally facing surface. The guard further includes a first armincluding a first free end and a second arm including a second free endextending generally axially in a distal direction from the base portion,the first free end extending beyond the second free end and including anangled end section comprising a first side edge, a second side edge, alength, and a width that extends toward the second arm. The guardincludes a needle tip holding space defined at least in part by the baseportion, the first arm, the second arm, and the angled end section. Theassembly further includes a needle having a tip and a diameter. Whereinthe first arm and the second arm are biased so as to move between aready position in which the angled end section abuts the needle and aprotected position in which the needle tip is confined within a tipholding space and wherein the length and width of the angled distal endsection are larger than the needle diameter and cooperate with the borelength and bore diameter to confine the needle tip within the needle tipholding space.

A still further feature of the present application is a method forassembling a needle assembly. The method comprising providing a needlehaving a needle shaft, a needle tip, and a change in profile near theneedle tip on a needle hub and placing a needle guard slidably about theneedle shaft. The needle guard comprising a non-metallic base portioncomprising wall having a bore, a bore length, a bore diameter, aproximally facing surface, and a distally facing surface. The needleguard further comprising a first arm including a first free end and asecond arm including a second free end extending generally axially in adistal direction from the base portion, the first free end extendingbeyond the second free end and including an angled end sectioncomprising a first side edge, a second side edge, a length, and a widththat extends toward the second arm. The needle guard further comprisinga needle tip holding space defined at least in part by the base portion,the first arm, the second arm, and the angled end section. Wherein thelength and width of the angled distal end section are larger than aneedle diameter and cooperate with the bore length and bore diameter toconfine the needle tip within the needle tip holding space. The methodfurther comprising moving the needle guard to a proximal position on theneedle shaft so that the angled end section is based by the needle shaftand is spaced from the needle tip.

BRIEF DESCRIPTION OF THE DRAWINGS

The various embodiments of the present needle assemblies and safety IVCsnow will be discussed with an emphasis on highlighting the advantageousfeatures. These embodiments depict the novel and non-obvious safety IVCshown in the accompanying drawings, which are for illustrative purposesonly. These drawings include the following figures, in which likenumerals indicate like parts:

FIG. 1 is a top view of a safety catheter having wings in accordancewith an embodiment:

FIG. 2 is a cross-sectional view of the safety catheter hub of FIG. 1including a needle in accordance with an embodiment:

FIG. 2A is a cross-sectional view of a modified safety catheter assemblyprovided in accordance with an embodiment:

FIG. 3A is a side view of a needle guard in accordance with variousembodiments:

FIG. 3B is an end view of the needle guard of FIG. 3A taken along line3B-3B:

FIG. 3C is a schematic top or plan view of the needle guard of FIG. 3Adepicting relationships between the width, length and bore diameter ofthe needle guard;

FIG. 4A is a side view of a needle guard in a protected positionaccordance with various embodiments:

FIG. 4B is a sectional view of the needle guard of FIG. 4A;

FIG. 5 is a side view of a needle guard in accordance with variousembodiments; and

FIG. 6 is a sectional view of an alternative configuration of the needleguard of FIG. 5 in accordance with an embodiment.

DETAILED DESCRIPTION

The detailed description set forth below in connection with the appendeddrawings is intended as a description of the presently preferredembodiments of safety IVCs provided in accordance with the presentapparatus, system and method and is not intended to represent the onlyforms in which the present apparatus, system and method may beconstructed or utilized. The description sets forth the features and thesteps for constructing and using the safety IVCs of the presentapparatus, system and method in connection with the illustratedembodiments. It is to be understood, however, that the same orequivalent functions and structures may be accomplished by differentembodiments that are also intended to be encompassed within the spiritand scope of the invention. Also, as denoted elsewhere herein, likeelement numbers are intended to indicate like or similar elements orfeatures.

The figures and their written descriptions indicate that certaincomponents of the embodiments are formed integrally and certain othercomponents are formed as separate pieces. Those of ordinary skill in theart will appreciate that those components shown and described herein asbeing formed integrally, in the alternative, may be formed as separatepieces. Those of ordinary skill in the art will further appreciate thatcomponents shown and described herein as being formed as separate piecesmay in alternative embodiments be formed integrally. Further, as usedherein the term integral describes a single piece, which may besingularly formed or singularly embodied whereas unitary meansmonolithically formed.

FIG. 1 is an illustration of a catheter housing 100 in accordance withan embodiment. The catheter housing 100 includes a catheter hub body102. The hub body or catheter hub 102 defines an internal chamber 104(FIG. 2) extending between a proximal end 106 and a distal end 108 ofthe hub body 102. A hollow catheter tube 112 is affixed at the distalend 108 of the hub body 102 using a bush or retainer 203 (FIG. 2), whichis known in the industry. An axial or proximal opening 110 is defined atthe proximal end 106 of the hub body 102. The axial opening 110 isconfigured to receive a hollow needle hub 90, which includes a needle202 on its distal end and a flash chamber at its proximal end. The axialopening 110 may embody a female Luer taper, which is typical in theindustry. Alternatively, the needle hub 90 abuts the end of the proximalend 106 but not enter the internal chamber 104. As used herein, the termdistal end or proximal end means an end in a distal general location orproximal general location, respectively, or distal most end or proximalmost end, respectively. If only a distal most end or a proximal most endis intended, the text will so indicate.

In some embodiments, the hub body 102 includes a port 114, which extendsfrom the hub body 102 in a direction generally perpendicular to theaxial direction of the internal chamber 104. In another embodiment, theport 114 is not included. In still yet another embodiment, the portcomprises a valve or a piston for regulating fluid flow through theopening of the port 114. For example, the port 114 and the valve mayembody a needleless access valve. Exemplary needleless access valves aredisclosed in U.S. Pat. Nos. 5,439,451; 6,036,171; and 6,543,745, thecontents of each of which are expressly incorporated herein byreference. Alternatively or in addition thereto, a plastic orelastomeric sleeve 82 (FIG. 2) may be used to control flow through theport 114, which is Well known in the industry. The sleeve 82 isconfigured to collapse upon application of fluid pressure caused by, forexample, a syringe. In some embodiments, wings 116 may be provided onthe hub body 102. The wings 116 may be positioned to extend out from thehub body in a plane perpendicular to the port 114, when the port 114 ispositioned on the hub body 102.

FIG. 2 is a cross-sectional view of the safety catheter hub 100 of FIG.1 in accordance with an embodiment. Generally, as shown in FIG. 2, aneedle 202 is received through the axial opening 110 and extends throughthe internal chamber 104. At the distal end 108 of the hub body 102, theneedle 202 extends into and through the tubular catheter 112 and theneedle tip extends beyond the distal end of the tubular catheter 112.

In one embodiment, a protective needle guard 204 is incorporated andslidably arranged on the needle 202. The needle guard 204 includes abase portion 205, which defines a bore 207 extending axiallytherethrough for receiving the needle 202. As described in greaterdetail below, the bore 207 is configured in size and shape to allow theneedle 202 to be slidably received therein. The needle guard 204 alsoincludes a first arm 206 and a second arm 208, which extend generallyaxially from the base portion 205.

The base portion 205 further comprises a wall comprising proximallyfacing wall surfaces 60 and distally facing wall surfaces 62 (See alsoFIG. 3A). A gap 50 is provided between the two arms 206, 208, which aredefined by the edges of the two arms and the distally facing wallsurfaces 62 of the base portion 205. The first arm 206 has a first freeor cantilevered end 210 and the second arm 208 has a second free orcantilevered end 212. The first free end 210 extends beyond the secondfree end 212 and has an angled end section 214, which may be referred toas a wall, a protective section, a blocking tip, or a cap. The angledend section 214 extends towards the second arm 208. In the embodimentshown, the angled end section 214, the first arm 206, and the baseportion 205 are formed contiguously or unitarily with one another. Also,as used herein, the term first and second are merely identifiers and donot necessarily limit the physical features of the arms. For example,when viewed from another perspective, the first arm may be called thesecond arm and vice-versa.

In one embodiment, the needle guard 204 is made from a unitary plastic,a thermoplastic, or an elastomer material or any combination thereof,such as a thermoplastic elastomer (TPE). For example, the needle guard204 may be made from shaped memory elastomer so that the first arm 206self-biases towards the second arm and the angled end section 214overlaps the end of the second arm, at least partially. Use of shapedmemory or resilient material permits the needle guard 204 to self-biasto a closed or protective position without external biasing forces, asfurther discussed below. More particularly, the first arm 206, thesecond arm 208 or both the first arm and the second arm are configuredto pivot radially inwardly to cover the needle tip with use of shapedmemory plastic or elastic material. Upon movement of the arm, the gap 50provided between the two arms is reduced. In other embodiments, theneedle guard 204 is made from multi-pieces and/or made from acombination of different materials, such as plastic and metal, e.g.,polycarbonate and stainless steel.

In the ready position of the safety catheter hub 100 shown in FIG. 2,the needle guard 204 is located at the proximal end 106 of the catheterhub 102. As shown, the needle guard is located substantially in theinterior of the internal chamber 104. It can also be wholly located inthe interior chamber 104 or partially located outside of the axialopening 110. The needle 202 extends through the bore of the needle guard204 and into the internal chamber 104. The needle extends distallythrough the catheter 112 so that the tip of the needle 202 extendsbeyond the distal end of the catheter tube 112. In the ready position,when the needle 202 extends through the needle guard 204, the angled endsection 214 is supported on the needle 202, such as contacted or abuttedby the needle, which causes the first free end 210 of the first arm 206to be forced or biased away from the second free end 212 of the secondarm 208. As shown, the cantilevered end 212 of the second arm 208 isalso biased by the needle in the ready position.

To axially locate the needle guard 204 within the catheter hub 102 inthe ready position and during transition from the ready position to aused position, the needle guard incorporates a hub engaging section 64and the hub 102 incorporates a guard engaging section 66. As shown, thehub engaging section 64 is a groove and the guard engaging section 66 isa projection that projects from the interior wall surface of the hub102. In another embodiment, the configuration is reversed so that thehub engaging section 64 is a projection and the guard engaging section66 is a groove. In one embodiment, the engagement is not circumferentialbut only partly around the needle guard so that only one of the arms isengaged to the huh. In another embodiment, the engagement iscircumferential around the needle guard. As shown, the hub 102incorporates both a recess and a projection. In another embodiment, thehub incorporates a projection to form an interior cavity of reduceddiameter but not a recess. When the angled end section 214 of the guardis in contact with the needle in the ready position, the needle pushesthe angled end section radially outwardly relative to the needle shaftso that the hub engaging section 64 engages the guard engaging section66 to retain the guard within the interior cavity of the hub 102.

FIG. 2A is a cross-sectional side view of a safety IVC 40 provided inaccordance with an embodiment of the present device and method. Thesafety IVC 40 is similar to the safety IVC 100 of FIG. 2 with someexceptions. Among other things, the interior cavity of the catheter hub104 has been modified to include an enlarged groove or recess 42 justdistal of the guard engaging section 66. This enlarged groove 42 isconfigured to accommodate the arcuate huh engaging section 64 on theneedle guard 44. As shown, when the needle guard 44 is in the readyposition, the guard engaging section 66 is spaced from the hub engagingsection 64. However, when the needle 202 is retracted away from thecatheter hub, such as after successful venipuncture, the needle guard 44moves relative to the catheter hub so that the hub engaging section 64abuts or engages the guard engaging section 66 by the relative movement.The engagement continues until the needle tip moves proximally of theangled end section of both first and second arms. At this point, thefirst arm 206 and the second arm 208 move radially inwardly to closeover the needle tip. Thus, a feature of the present embodiment is aguard having a huh engaging section that is spaced from the catheter huhin a ready position and only engages or abuts the catheter hub uponrelative movement.

If the proximal end of the needle guard 204 is flush with the proximalend 106 of the catheter hub 102, or projects outwardly from the proximalend of the catheter hub 102, the needle hub (not shown) may be assembledto the catheter hub by providing a shroud on the needle hub to fit overthe catheter huh. In an alternative configuration, the needle guard 204is recessed inside the catheter hub and a space is provided for a distalend section of the needle huh to fit inside the proximal end of thecatheter hub.

In one embodiment, if shaped memory elastomer or non-metallic materialwithout self-biasing is used, the arms 206, 208 may be biased togetherusing any form of tensioning. In other embodiments, a combination oftensioning means and self-biasing non-metallic material is used. Asillustrated schematically in FIG. 3A, a tensioning member 218 may bedeployed in a region of the needle guard 204 between the base portion205 or proximal wall and the first and second free ends 210 and 212. Inone embodiment, the tensioning member 218 may be a ring made from anelastic material, such as rubber material, silicone or the like, that ismade to fit around the first and second arms 206 and 208. The ringexerts a restoring force on the arms, when the arms are spread apart bythe needle 202, as in the ready position. In one embodiment, thetensioning member 218 may be a spring, such as a helical coil spring, aleaf spring or other similarly functioning types of springs. In oneembodiment, the tensioning member 218 may not be a separate component ofthe needle guard 204. In this embodiment, one or both of the arms 206and 208 may be made of a material that has inherent spring-likeproperties. The inherent spring-like properties cause an inherentrestoring force to be stored in the arms when the arms are spread apartby the needle 202 as when in the ready position. Once the needle 202 isremoved from contact with the first arm 206, the arms naturally returnto the protected position. One or more chamfered surfaces 80 and one ormore surface features 68, such as indentations or grooves, may beincorporated for aesthetic appeal and/or to facilitate furtherresiliency to promote installation. In other embodiments, undercuts orother surface features may be added to facilitate assembly of thetensioning member 218. In one embodiment, a helical spring is fined overthe entire needle guard so that axial force from the spring expansionforces the two arms to move radially inwardly.

In operation, the distal tip of the needle 202 and the catheter tube 112are inserted into a patient's vein to establish venipuncture.Thereafter, the health care practitioner manually withdraws the needle202 from the catheter hub 102. A male luer of an intravenous (IV) lineattached to the catheter hub may then be fitted with a source of a fluidthat is to be administered into the patient's vein.

As the needle 202 is withdrawn from the patient following successfulvenipuncture, the needle slides proximally relative to the catheter tubewhile maintaining contact with the angled end section 214 of the needleguard to removably secure the guard to the hub. Once the needle tipmoves proximally of the angled end section 214 of the guard, the firstarm 206, which is now no longer forced outwardly by the needle, movesradially inwardly to separate the hub engaging section 64 from the guardengaging section 66 to cover the needle tip with the angled end section214. Further proximal movement of the needle causes a change in profile402 (FIG. 2) located on the needle shaft to abut the opening 207 on theproximal wall of the guard to stop relative movement between the needleguard and the needle. At that point, the needle guard may be from thecatheter hub due to the abutment between the change in profile and theopening on the needle guard. Causing the needle guard to separate fromthe needle hub to protect the needle tip is further discussed below.

It should be understood that the general configuration and operation ofthe safety catheter hub 100 thus described provides a context in whichthe following embodiments of the needle guard may be used to ensureproper and adequate protection to health care practitioners using thesafety catheter hub 100. It should further be understood that each ofthe embodiments described herein may be used separately or incombination with one another, as appropriate and as desired, such aswhere the functions or features are compatible.

Referring again to FIG. 3A, in an embodiment of a needle guard 300, thelength of the angled end section 214 may be designated by the variableLn, wherein n is a whole integer, such as 1, 2, 3, and so forth. Thewidth (height) of the angled end section 214 may be designated by thevariable W, which is more clearly shown in end-view 3B-3B. In oneembodiment, the length Ln and width W are selected so that the angledend section 214 is configured to adequately block the needle tip whenthe needle guard is in the protected position. In one particularembodiment, the length Ln and the width W of the guard are selected sothat the tip is blocked or covered by the end section 214, even when theneedle is rotated so the point of the bevel still faces the end section214 or when the needle pivots side-to-side when in the protectedposition. In addition, the width W and the length Ln are to be wideenough to prevent the needle bevel from contacting an edge of the angledend section 214 since some plastics such as polycarbonate or ABS can bechipped when struck by the needle bevel. Thus, a feature of the presentdevice, assembly, and method is a needle guard having a non-metallicbase portion or proximal wall comprising a bore, a proximally facingsurface, and a distally facing surface, and wherein the bore and thebase portion can be distorted by pivoting the needle but wherein suchpivoting does not cause the needle tip to escape from the confines of anangled distal end section due to the length and width of the angleddistal end section. In one example, the length is about the samedimension as the width W for a wide needle guard. In another example,the length is about 1.3 or more times greater than the width W, such as2×, 3×, or 4× greater than the width W. Compared to the diameter of theneedle, the width W is preferably 1.25× or greater than the diameter ofthe needle, such as 2.5×, 3×, or greater than the diameter of theneedle.

In one embodiment, the length L₁ is selected such that the angled endsection 214 protrudes over at least a portion of the second free end 212when the first and second arms 206 and 208 are in the protectedposition. Alternatively, the length L may be selected such that theangled end section 214 protrudes over between at least a portion of thesecond free end 212 to over the entire second free end 212 when thefirst and second arms 206 and 208 are in the protected position. Inanother alternative embodiment, the length L₂ may be selected such thatthe angled end section 214 protrudes entirely over and beyond the secondfree end 212 when the first and second arms 206 and 208 are in theprotected position. Thus, for example, the length Ln may be selected tocause the angled end section 214 to protrude over a fraction of thesecond free end 212, between over a fraction to 100% of the second freeend 212 or over 100% of the second free end 212 when the first andsecond arms 206 and 208 are in the protected position.

Similarly, the Width W of the angled end section 214 may be selectedsuch that the angled end section 214 is greater in width W than thewidth of the second free end 212 when the first and second arms 206 and208 are in the protected position. Thus, for example, the width W may beselected to be greater than the width of the second free end 212 betweena fraction of to about 50% greater than the width of the second free end212 when the first and second arms 206 and 208 are in the protectedposition. It should be understood that the selection of the length Lnand the width W may be made independent of the selection of the otherdimensions. As shown in FIG. 3B, the width W and the length Ln arealways larger than the outside diameter D of the needle 202, so that nomatter how the needle is rotated or pivoted in the bore 207 duringwithdrawal, the needle tip and the bevel are always blocked by theangled end section 214. Thus, the angled end section 214, when in theprotected position, creates a space there behind, which is defined by alength and a width of the angled distal end section 214 being greaterthan the outside diameter D of the needle. In one embodiment, the widthis at least 125% greater than the diameter of the needle and the lengthis at least 200% greater than the diameter of the needle. In otherembodiments, the width is from about 150% to about 300% greater than ediameter of the needle. The disclosed length and width along with thebore 207 at the proximal end are configured to retain the needle tipwithin the open area 304 within the needle guard.

To further facilitate protection of the needle tip, the angled endsection 214 of the needle guard may incorporate a shield member orinsert 306. The shield member 306 may be made of a puncture resistantmaterial, such as a metal insert or a hard plastic insert. The shieldmember 306 resists puncturing of the angled end section 214 by theneedle tip once the needle has been captured by the needle guard 300.For example, when the guard is made from an elastomer material, theshield member 306 may be incorporated, such as by co-molding or insertmolding, to prevent exposure of the needle tip penetrating through theangled end section 214. In another embodiment, the shield member 306 ispositioned on an external surface of the angled end section 214, forexample on the distal surface 308 or the proximal surface 310 of theangled end section. The shield member 306 may be mounted to the externalsurface using any well-known means of bonding components together, suchas gluing, welding and the like.

FIG. 3C is a schematic to or plan view of the needle guard 300 in ashielded or protected position, which captures the needle tip 196 withinthe open area 304 of the needle guard. As the needle guard 300 is made,at least in-part, from a non-metallic material that has a lower strengthand hardness than a metallic material, the needle can pivot along afirst angle, as shown by dashed-dot line 30, or along a second angle, asshown by dashed-dot line 32. In pivoting, the needle can abut the bore207 at points 34 and 36 and/or corresponding points at the distal edgeof the bore 207 and possibly compress or distort part of the bore tofurther pivot. When this happens, the needle tip 196 moves within theconfined open space or needle tip holding space 304 and can slip pastthe side edges 38 of the needle guard, near the angled end section 214.However, as discussed above, by selecting an appropriate width W andlength ratio, the needle tip is prevented from slipping past the sideedges 38. Alternatively or additionally, the bore 207 inside diametermay be made to have a close fit ratio versus the outside diameter of theneedle shaft to minimize the amount of possible pivoting. The borelength can also be utilized in combination with the bore diameter tominimize the amount of possible pivoting. Still furthermore, arelatively harder insert may be incorporated with the bore 207 or insidethe bore 207 to not only increase the separation force of the needle, asfurther discussed below, but to also minimize the amount of possibleneedle pivoting.

FIG. 4A is a side view of a needle guard 400 located over a needle 202in a protected position. The needle 202 has a substantially constantcross section, i.e., a nominal diameter, along the length of the needle202 except for a change in profile 402 provided near the needle tip atthe distal end of the needle 202. The change in profile may be viewed asa needle section having a different dimension than the nominal diameterand may be created using various means. In one embodiment, the change inprofile 402 is made by crimping a portion of the needle 202, eitheralong both sides or symmetrically along the circumference of the needleor alternatively only on one side or point on the circumference of theneedle. The crimping process creates an indentation along one plane ofthe needle and an enlargement along another plane of the needle. Thechange in profile 402 may also be formed by adding material onto theouter surface of the needle 202 or by adding a sleeve to the needle. Theadded material may include an adhesive, a resin or a metal material. Assuch, the change in profile may be referred to as a bulge, which caninclude a section of the needle with added material, a crimp, a sleeve,a bulge, or combinations thereof.

As shown in FIGS. 4A and 4B, the position of the change in profile 402formed on the outer surface of the needle 202 is selected such that thechange in profile 402 abuts or comes close to the distally facing side62 of the base portion 205 of the needle guard 400 substantially atabout the same time or moment as when the needle tip moves proximally ofthe angled end section 214 of the first arm 206. The change in profile402, or at least the widest most point of the change in profile, islarger than the dimension of the bore 207 of the base portion 205. Thus,the needle tip of the needle 202 is prevented from moving proximally ofthe base portion 205 due to the relative dimensions of the change inprofile 402 and the opening of the bore 207.

In some embodiments, the pull-off strength, detachment force, orseparation force to separate the needle from the guard may be increasedby incorporating an insert 404 to the bore 207. As shown in FIGS. 4A and4B, instead of abutting directly against the material from which theneedle guard 400 is made (e.g., plastic, elastomer, or TPE), the changein profile 402 may be made to at least partially abut the insert 404,which can be made from a metal, such as a stainless steel sleeve ortube. The metal-to-metal contact between the change in profile 402 andthe metal insert 404 increases the pulling force required to pull thechange in profile 402 through the bore 207 during use. In anotherembodiment instead of a metal insert, the insert may be made from aharder plastic material than the base material used to form the tipprotector. By incorporating an insert 404 to the bore 207 of the tipprotector 300, the detachment force can be made to increase by at least100% over an opening made from a plastic, elastomer, or TPE material.

In one example, a detachment force to separate a needle from apolycarbonate tip protector has been found to be around 5 Newtons (N).Whereas with a metallic tip protector, separation is more difficult anda detachment force of about 20 N or more, such as 30 N, has been foundto be achievable. Thus, a feature of the present device and method is asafety IVC comprising a needle hub, a catheter hub, and a tip protectormade from a first material having an insert aligned with a proximalopening of the tip protector made from a second stronger material.Wherein a detachment force to separate the needle from the tip protectoris at least 100% greater than a comparable safety IVC having a tipprotector made only from the first material. For example, the detachmentforce can be 200%, 300%, or 400% greater than the comparable safety IVChaving a tip protector made only from the first material. In a specificexample, the detachment force is about 600% greater than a comparablesafety IVC having a tip protector made only from the first material.Thus, an opening on the proximal wall or base section 205 of the tipprotector may be enlarged easier by the change in profile located on theneedle than for the opening of the insert element, which translates togreater detachment force.

Thus, an aspect of the present safety IVC and method is a multi-piecetip protector made from a first material, such as an elastomer or TPEmaterial, located at least partially within a catheter huh. Wherein aninsert comprising an insert bore made from a second material is coupledto a proximal wall of the tip protector to form a multi-piece tipprotector and to increase the detachment force of the multi-piece tipprotector and a needle comprising a change in profile compared tosimilar safety IVCs where no insert is incorporated. In a particularembodiment, the insert is a metallic plate or sheet. The coupling may bemechanical, co-molding or insert-molding, or bonding, such by adhesiveor laser. In another embodiment, the insert is a metal sleeve or tube.In yet another embodiment, the insert increases the force required topivot the needle, unintentionally or otherwise, relative to a bore ofthe proximal wall compared to the same safety IVCs without the insert.The insert comprises a bore or an opening that is aligned with the boreor opening of the needle guard. As previously described, the insert maybe a plate or a sleeve and may be co-molded or insert molded with theneedle guard or attached to an external surface of the needle guard.

A further aspect of the present device and method is a safety IVCcomprising a tip protector made from a first material, such as anelastomer or a TPE, and having a proximal wall comprising an openingdefining a bore and two arms extending distally of the proximal wallwith one of the arms comprising an angled end section configured forcovering a distal end of the other arm in a protective position; andwherein an insert made from a second material comprising an opening isaligned with the opening of the proximal wall. A further feature ofsafety IVC is a shield member made from a third material, which isdifferent from the first material, coupled to the angled end section. Inone example, the second material is the same as the third material. Instill yet another example, the angled end section is both longer andwider than the distal end of the other arm.

Advantageously, use of the metal insert 404 to increase the pullingforce allows for a reduction of the size of the change in profile 402.For example, when the change in profile is a crimp, the extent ofcrimping may be reduced when the change in profile is pulled against abase portion 205 of a non-metallic needle guard having an insert 404.This allows for the use of a more conventional catheter tube andfastening bush 203 (FIG. 2) used to affix the catheter tube to thecatheter hub compared to a similar needle size used with a non-metallicneedle guard without an insert. In other words, if an insert is notincorporated, a larger crimp may be required to prevent separation fromthe opening of the needle guard. Which in turn requires a relativelarger catheter tube to accommodate the larger crimp. Thus, byincorporating an insert, the needle crimp may be made to industrystandard without having to over crimp the needle in an attempt toincrease the detachment force, which requires a corresponding oversizedcatheter tube and fastening bush 203 to accommodate an otherwiseenlarged crimp. Moreover, since the change in profile can be madesmaller when used with a needle guard having an insert, the internalprofile of the needle for enabling adequate fluid flow, which candecrease due to over crimping, can remain relatively large. Similarly,in embodiments in which the change in profile is made by adding materialto the needle, the amount of material added to the needle to create thechange in profile may also be reduced. Patients can benefit from thepresent design, which is configured to permit optimum crimping size anddetachment force without having to oversize the needle and the cathetertube, which can lead to more painful venipuncture procedures. Saiddifferently, the present device and method permit a relatively smallerneedle size to be used compared to a similar safety IVC having a needlethat is otherwise over crimped to work with a needle guard made from anelastomer or TPE without an insert.

Referring again to FIG. 4A, a tip holding space 70 is defined by an areabehind the angled end section 214, the free end or cantilevered end 212of the second arm 208, and the extent of travel when the needle 202pivots side-to-side to move in and out from the plane defined by FIG.4A. By sizing the angled end section with an appropriate length andwidth, the needle tip and the bevel section of the needle tip isretained within the tip holding space 70 regardless whether the needlepivots or rotates within the bore 207 and with or without an insert 404.

FIG. 5 is a side view of a needle guard 500 provided in accordance withanother embodiment of the present assembly and method. As shown, thefirst arm 502 and the second arm 504 may each be made either completelyor partially of a metal material. For example, the first arm 502 of theneedle guard 500 may be made from a metal material but not the secondarm, which may be made from a plastic, an elastomer, or a TPE. Themetallic first arm 502 may be coupled to the second arm 504 of theneedle guard 500 using known prior art means, such as by insert-molding.Welding or by adhesive. In some embodiments, the metal first arm 502 isattached to a base portion 506 of the needle guard 500. In theembodiment shown, the base portion 506 is made from the same material asthe second arm 504. In other embodiments, the base portion 506 is madefrom a metal material. The base portion 506 of the various embodimentsincludes a bore 207 extending therethrough in the axial direction forreceiving the needle 202. The base portion 506 further has proximally 60and distally 62 facing wall surfaces.

In one embodiment, the first arm 502 may be formed from a strip of sheetmetal having spring-like properties. In this embodiment, the first arm502 includes a base section 508 and a delectable section 510. The basesection 508 is coupled to the base portion 506. In one embodiment, thebase section 508 of the first arm 502 lies against an outer surface ofthe base portion 506. The base section 508 of the first arm 502 may besecured to the base portion 506 using conventional methods, such as byadhesive, welding or insert-molding.

In an alternative embodiment shown in FIG. 6, a proximal face 602 may becreated by bending a portion of the base section 508 of the first arm502 around the base portion 506 of the needle guard to lie against theproximal outer surface 60 of the base portion 506. In this embodiment,the bottom face 602 defines a hole that lies concentrically with thebore 207 to allow the needle 202 to be inserted therethrough. The bottomface 602 is configured to increase the pulling force required to pullthe change in profile 402 completely through the bore 207 during use,i.e., the detachment force. In another embodiment, the bottom face 602is insert-molded to the needle guard and is positioned internally of thebase portion 506 or on the distal wall surface of the base portion.Optionally, the base portion 506 also includes an insert 404 in additionto the bottom face 602.

Referring again to FIG. 5, the deflectable section 510 of the first arm502 includes a distal angled end section 512. The angled end section 512is angled inwards, towards the second arm 504. The angled end section512 may have a length that extends over at least a fraction of a percentto over 100% of the second arm 504. In one embodiment, the angled endsection 512 may have a generally V-shape with the peak of the V pointingin the axial direction and the free leg of the V extending in thedirection of the second arm 504.

In one embodiment, one or more rib members 514 may be added to the firstarm 502. The rib members 514 are provided on the first arm 502 to addstrength to the arm. To provide the added strength, the rib members 514may extend axially along the entire length of the first arm 502 or mayextend only along a portion of the first arm 502. For example, a ribmember may extend substantially along only the axial length of thedeflectable section 510. When the deflectable section 510 of the firstarm 502 is biased away from the second arm 504, the rib member 514 aincreases the amount of resistance with which the first arm resists thebiasing. Thus, when the biasing is removed, the deflectable section 510of the first arm 502 is more quickly and reliably moved back to theprotected positioned. In addition, once in the protected position, thestiffening of the first arm 502 by the rib member 514 a makes it moredifficult to inadvertently deflect the deflectable section 510 of firstarm 502.

In one embodiment, the needle guard 500 may include one or a pair offlaps 516. The flaps 516 may be included as an extension of the firstarm 502 that are bent 90 degrees or more towards the open area 520. Theflaps 516 extend from the first arm 502 into an open area 520 defined inthe open space between the first arm 502 and the second arm 504. In thismanner, the flaps 516 provide a semi-closure to the open area 520, whichhelps to keep the needle tip confined behind the angled end section 512.

Alternatively, or in addition to, the flaps 522 may be positioned on theangled end section 512. The flaps 522 may be made as extensions of a topand bottom surface of the angled end section 512. The flaps 516 and 522may be formed integrally with the corresponding first arm 502 and angledend section 512. The flaps may also later be attached to thecorresponding first arm 502 and angled end section 512, such as by usingan adhesive, by welding the flaps thereto or by using other similarlysuitable attaching methods known in the art.

In embodiments in which the second arm 504 is made of a non-metal, metalor non-metal flaps 524 may be added to the second arm. The flaps 524 maybe added using adhesives or other similarly suitable attaching methodsknown in the art. The second arm may be made completely or partially outof metal.

In each embodiment, the flaps 516, 522 and 524 are dimensioned such thatthe needle tip is blocked from exiting the open area 520 when the firstand second arms 502 and 504 are in the protected position. For example,the flaps 516 and 524 may extend from each arm into the open area 520 adistance up to or over the axial centerline of the needle guard 500. Inanother example, the flaps 522 may extend from the angled end section512 into the open area 520 a distance that causes the flaps 522 toprotrude over a portion of the needle 202.

The above description presents the best mode contemplated forestablishing a needle safety device and associated methods and of themanner and process of making and using it in such full, clear, concise,and exact terms as to enable any person skilled in the art to which itpertains to make and use this apparatus. This apparatus is, however,susceptible to modifications and alternate constructions from thatdiscussed above that are fully equivalent. Consequently, this apparatusis not limited to the particular embodiments disclosed and certainfeatures disclosed for one embodiment may be incorporated in anotherembodiment provided their functions are compatible. On the contrary,this apparatus covers all modifications and alternate constructionscoming within the spirit and scope of the apparatus as generallyexpressed by the following claims, which particularly point out anddistinctly claim the subject matter of the apparatus. Further, theembodiments illustratively disclosed herein suitably may be practiced inthe absence of any element, which is not specifically disclosed herein.

What is claimed is:
 1. A needle assembly comprising: a needle comprisinga needle shaft having a lengthwise axis, a needle tip having a bevel anda point at an end of the bevel, and a diameter; a needle guard having anon-metallic base portion comprising a wall having a bore, a borelength, a bore diameter, a proximally facing surface, and a distallyfacing surface; a first arm including a first free end and a second armincluding a second free end, the first and second free ends extendinggenerally axially in a distal direction from the base portion; the firstfree end extending beyond the second free end and including an angledend section, which comprises a length extending towards the second armand a first side edge and a second side edge defining a width; thelength and width of the angled end section defining an area orthogonalto the lengthwise axis of the needle shaft, and the second armcomprising a distal end most surface comprising a length and a widthorthogonal to the lengthwise axis of the needle shaft; a metallic insertcomprising an opening attached to the non-metallic base portion; aneedle tip holding space defined at least in part by the non-metallicbase portion, the first arm, the second arm, and the angled end sectionfor retaining the needle tip within the needle tip holding space in aprotected position; wherein the first arm is biased towards the secondarm so as to move between a ready position in which the angled endsection abuts the needle shaft and the protected position in which theneedle tip is confined within the needle tip holding space; wherein theneedle extends through the metallic insert; and wherein the width of theangled end section of the first arm is dimensioned so as to confine theneedle tip within the needle tip holding space, is at least 2 timesgreater than the diameter of the needle, is selected based at least inpart on the bore length and the bore diameter, and is selected to retainthe needle tip within the needle tip holding space proximal of theangled end section when the bevel of the needle tip rotates, when theneedle pivots side-to-side when in the protected position, or both whenthe bevel rotates and the needle pivots side-to-side relative to theneedle guard.
 2. The needle assembly of claim 1, wherein the metallicinsert is co-molded, insert molded, bonded, or laser attached to thenon-metallic base portion.
 3. The needle assembly of claim 2, whereinthe width of the angled end section is at least 3 times greater than thediameter of the needle.
 4. The needle assembly of claim 1, furthercomprising a catheter hub with an interior cavity and wherein thenon-metallic base portion, the first arm, and the second arm aredisposed, at least in part, inside the interior cavity of the catheterhub.
 5. The needle assembly of claim 4, wherein the needle is attachedto a needle hub.
 6. The needle assembly of claim 5, wherein the catheterhub has a guard engagement section and the needle guard has a hubengagement section and wherein the two engagement sections are removablyengaged to one another inside the catheter hub.
 7. The needle assemblyof claim 5, wherein the needle comprises a change in profile near theneedle tip for engaging the metallic insert.
 8. The needle assembly ofclaim 7, wherein the width of the angled end section is at least 3 timesgreater than the diameter of the needle.
 9. The needle assembly of claim5, further comprising a shield member positioned in or on the angled endsection of the first arm to prevent penetration through the angled endsection by the needle.
 10. The needle assembly of claim 5, wherein thewidth of the angled end section is 2.2 times or greater than thediameter of the needle to prevent the needle tip from extending beyondthe first side edge or the second side edge of the angled end sectionwhen the needle pivots, rotates, or both pivots and rotates.
 11. Theneedle assembly of claim 10, wherein the width of the angled end sectionis at least 3 times greater than the diameter of the needle.
 12. Theneedle assembly of claim 10, further comprising a shield memberpositioned in or on the angled end section of the first arm to preventpenetration through the angled end section by the needle.
 13. The needleassembly of claim 1, wherein the width of the angled end section isgreater than the width of the distal end most surface of the second arm.14. The needle assembly of claim 13, wherein the width of the angled endsection of the first arm is at least 1.1 times larger than the width ofthe distal end most surface of the second arm.
 15. A method forassembling a needle assembly comprising: providing a needle extendingfrom a needle hub, the needle having a needle shaft having a diameter, alengthwise axis, a needle tip, and a change in profile near the needletip; placing a needle guard slidably about the needle shaft; said needleguard comprising: a base portion comprising a wall having a bore, a borelength, a bore diameter, a proximally facing surface, and a distallyfacing surface; and a first arm including a first free end and a secondarm including a second free end, said first and second arms extendinggenerally axially in a distal direction from the base portion, the firstfree end extending beyond the second free end and including an angledend section, which comprises a length and a first side edge and a secondside edge defining a width forming an area orthogonal to the lengthwiseaxis of the needle shaft, and the second arm comprising a distal endmost surface comprising a length and a width orthogonal to thelengthwise axis of the needle shaft; a needle tip holding space definedat least in part by the base portion, the first arm, the second arm, andthe angled end section for retaining the needle tip within the needletip holding space in a protected position; wherein the width of theangled end section is at least 2 times greater than the diameter of theneedle, is selected based at least in part on the bore length and thebore diameter, and is selected to confine the needle tip within theneedle tip holding space proximal of the angled end section as theneedle guard pivots, rotates, or both pivots and rotates on the needleshaft; and moving the needle guard to a proximal position on the needleshaft so that the angled end section is biased by the needle shaft andspaced from the needle tip.
 16. The method of claim 15, furthercomprising placing the needle guard at least in part inside an interiorcavity of a catheter hub, which has a catheter tube attached thereto.17. The method of claim 15, wherein the change in profile engages aninsert coupled to the base portion of the needle guard when the needleis retracted in the protected position.
 18. The method of claim 17,wherein the insert is aligned to the bore at the base portion of theneedle guard.
 19. The method of claim 18, further comprising a shieldmember positioned in or on the angled end section of the first arm toprevent penetration through the angled end section by the needle. 20.The method of claim 17, wherein the width of the angled end section isabout 1.1 to about 1.5 times larger than the width of the distal endmost surface of the second arm.
 21. The method of claim 17, wherein thelength of the angled end section is such that the angled end sectionextends over and covers the distal end most surface of the second freeend in the protected position.
 22. The method of claim 17, furthercomprising rotating the needle or pivoting the needle relative to theneedle guard.
 23. The method of claim 22, wherein the needle tip isblocked by the angled end section of the first arm.
 24. The method ofclaim 14, wherein the width of the angled end section is at least 2.2times or greater than the diameter of the needle to prevent the needletip from extending beyond the first side edge or the second side edge ofthe angled end section when the needle pivots, rotates or both pivotsand rotates relative to the needle guard.
 25. The method of claim 24,further comprising sizing the width of the angled end section to be 3times or greater than the diameter of the needle.